UMIN-CTR Clinical Trial

Basic information
Public title	Impact of music therapy in post-stroke aphasia patients
Acronym	Impact of music therapy in post-stroke aphasia patients
Scientific Title	Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Scientific Title:Acronym	Primary verification of the impact of listening to songs with lyrics in post-stroke aphasia patients
Region	Japan

Condition
Condition	Post-stroke aphasia
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An initial investigation into whether listening to music with lyrics improves aphasia in subacute stroke patients, and if so, in what aphasia classifications and in what symptoms of aphasia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in WAB-AQ(Western Aphasia Battery-Aphasia quotient) before and after the 3-month intervention period
Key secondary outcomes	The change in each subset score of the WAB(Western Aphasia Battery) before and after the 3-month intervention period

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Three months of free listening to music with lyrics of the patient's choice for at least one hour per day. Every two weeks, a 15-minute interview with a physician or nurse to check and improve adherence to music listening
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	First stroke patients admitted to the Recovery Rehabilitation Unit of Murayama Medical Center, within 60 days of onset, with aphasia scoring 4 or less on the severity scale of the Boston Diagnostic Aphasia Evaluation, whose attending physician deems them appropriate and who have given written consent
Key exclusion criteria	Native language is not Japanese, severe hearing impairment
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Suzuki
Organization	Saiseikai Higashikanagawa Rehabilitation Hospital
Division name	Department of Rehabilitation medicine
Zip code	221-0822
Address	1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL	045-324-3600
Email	someguya617@gmail.com

Public contact
Name of contact person	1st name Toshiyuki Middle name Last name Suzuki
Organization	Saiseikai Higashikanagawa Rehabilitation Hospital
Division name	Department of Rehabilitation medicine
Zip code	221-0822
Address	1-13-10, Nishi-Kanagawa, Kanagawa-ku, Yokohama, Kanagawa
TEL	045-324-3600
Homepage URL
Email	someguya617@gmail.com

Sponsor
Institute	Murayama Medical Center, department of Rehabilitation medicine
Institute
Department

Funding Source
Organization	Murayama Medical Center, department of Rehabilitation medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Murayama Medical Center
Address	2-37-1 Gakuen, Musashimurayama, Tokyo
Tel	042-561-1221
Email	218-murayamahome@mail.hosp.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2022 Year 06 Month 15 Day
Date of IRB	2022 Year 03 Month 15 Day
Anticipated trial start date	2022 Year 06 Month 15 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 08 Day
Last modified on	2022 Year 06 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054700

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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